# DRT: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

- Device class: 2; regulation: 21 CFR 870.2300; FDA's rule: 510(k) required
- FDA decisions: 341
- 510(k) review time 2021–2025: median 242 days (middle half 212–294)
- Recalls: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 1
- 2017: 1
- 2018: 1
- 2019: 1
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 3
- 2025: 1
- 2026: 5

## Most-cited predicates
- K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 (2001), cited by 13
- K882609: Models M1175A & M1176A Component Monitoring System (1989), cited by 8
- K952474: Eagle 3000 Patient Monitor (1995), cited by 5
- K911139: Hewlett-Packard Models M1400A, M1402A & M1401A (1991), cited by 4
- K052446: LG1 Intelligent Medical Vigilance System (2006), cited by 4
- K002725: Micropaq, Models 402 and 404 (2000), cited by 4
- K043517: Transmitter, ZS-940PA Series (2005), cited by 3
- K001775: Zoe Medical Nightingale Monitoring System (2001), cited by 3
- K082626: PAM 3000 (2009), cited by 3
- K021681: Micropaq, Models 402, 404 (2002), cited by 3

Source page: https://510kreport.com/product-code/DRT
Data by year (CSV): https://510kreport.com/product-code/DRT.csv